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Study of A3309 in Patients With Dyslipidemia

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ClinicalTrials.gov Identifier: NCT01069783
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Albireo

Brief Summary:
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with dyslipidemia (high cholesterol levels).

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: A3309 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia
Study Start Date : February 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A3309 low dose Drug: A3309
A3309 in two different dosage levels
Drug: A3309
A3309 in two different dosage levels for the duration of the study
Experimental: A3309 high dose Drug: A3309
A3309 in two different dosage levels
Drug: A3309
A3309 in two different dosage levels for the duration of the study
Placebo Comparator: Placebo Drug: Placebo
Placebo comparator once daily for the duration of the trial



Primary Outcome Measures :
  1. Change from baseline in low-density lipoprotein (LDL) cholesterol [ Time Frame: eight weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients meet protocol specified criteria for dyslipidemia and has successfully completed study requirements with no clinically relevant findings

Exclusion Criteria:

  • Medical history or medical condition that would not make the patient a good candidate for the study or would limit the patient´s capability to complete the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069783


Locations
Sweden
BCRC
Linköping, Sweden
Sponsors and Collaborators
Albireo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Albireo
ClinicalTrials.gov Identifier: NCT01069783     History of Changes
Other Study ID Numbers: A3309-005
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Albireo:
dyslipidemia
cholesterol
LDL

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases